ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC (ENTRATA)

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Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Karnofsky Performance Score (KPS) ≥ 70%

Estimated Life Expectancy of at least 3 mo

Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.

Measurable Disease per RECIST 1.1 as determined by the Investigator

Must have received at least two prior lines of systemic therapy, including at least one VEGFR-targeting TKI (e.g., sunitinib, sorafenib, pazopanib, cabozantinib)

a) Radiographic progression of mRCC must have occurred (per investigator assessment) on or after the most recent systemic therapy and within 6 mo prior to C1D1.

Prior treatment with other anti-cancer therapies including cytokines, monoclonal antibodies, immunotherapies, and cytotoxic chemotherapy is allowed

Exclusion Criteria:

Prior treatment with mTOR inhibitors (everolimus or temsirolimus) or CB-839

Receipt of any anticancer therapy within the following windows before randomization:

Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.

Unable to receive medications PO or any condition that may prevent adequate absorption of oral study medication

Major surgery within 28 days prior to randomization

Patients with active and/or untreated central nervous system (CNS) cancer are not eligible. Patients with treated brain metastasis must have 1) documented radiographic stability of at least 4 weeks duration demonstrated on baseline contrast-enhanced CNS imaging (eg contrast-enhanced MRI of the brain) prior to randomization and 2) must be symptomatically stable and off steroids for at least 2 weeks before randomization.